Below is a partial listing of currently enrolling U.S. clinical trials gathered from various sources. As of August 2004, TrialSearch -- an extensive online database of clinical trials related to HIV/AIDS -- has been operated by the AIDS Community Research Initiative of America (ACRIA). The University of California at San Francisco's HIV InSite web site (which formerly offered TrialSearch) now features TrialScope, a database of organizations that conduct HIV/AIDS-related research.

The federal government's AIDSinfo web site includes a section on clinical trials. It features an introduction to HIV/AIDS research and study listings from the National Institutes of Health's ClinicalTrials.gov database. AIDSinfo also has a toll-free phone service at 800-874-2572, available Monday through Friday 12:00 pm to 4:00 pm ET (9:00 am to 1:00 pm PT), to help locate trials and answer questions. Like ClinicalTrials.gov, the CenterWatch web site also includes trial listings for all diseases including HIV/AIDS and related conditions.

The National Center for Complementary and Alternative Medicine (NCCAM) provides a listing of alternative therapy studies for conditions related to HIV or its treatment. The HIV Vaccine Trials Network (HVTN) is an international collaboration testing preventive vaccines against HIV/AIDS. Community Programs for Clinical Research on AIDS (CPCRA) is a nationwide network that conducts community-based clinical trials. In addition to hosting TrialSearch, ACRIA also provides a listing of trials mostly in the mid-Atlantic region (New York, New Jersey, Connecticut, and Pennsylvania).

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The Body web site has created a new database of prospective clinical trial volunteers. The service collects information about participants' city, age, viral load, CD4 cell count, current and past anti-HIV therapy, and health status. Researchers can request information about prospective subjects, who will be contacted if they meet a trial's enrollment criteria. The application form is available at http://ssl.thebody.com/submit/?/clinicaltrials/general.html.

Call the telephone numbers listed for each study or see the indicated web sites for more information about specific trials and additional study sites. Protocol (study) numbers, if available, are provided in parentheses at the end of the trial descriptions.

Tipranavir Open-Label Study

This expanded open-label study, sponsored by Boehringer Ingelheim, will provide access to tipranavir, an investigational nonpeptidic protease inhibitor (PI). This past autumn the company requested Food and Drug Administration approval to market the drug. This nonrandomized trial will provide tipranavir to treatment-experienced individuals who are not benefiting from or unable to tolerate their current therapy and need a new PI to construct a viable regimen. All subjects will receive tipranavir plus ritonavir (Norvir); there is no placebo arm. Safety evaluations will be performed at regular intervals.

Prospective subjects must be at least 13 years old and must be unable to achieve virological suppression on their current antiretroviral regimen, with a maximum CD4 cell count of 100 cells/mm3 and/or a viral load of 10,000 copies/mL or greater. They must not have certain medical conditions and may not be taking certain other drugs. Women may not be pregnant or breast-feeding and must agree to use effective contraception.

The study is being conducted at more than 60 sites, including Atlanta, Baltimore, Boston, Chicago, Cincinnati, Detroit, Houston, Las Vegas, Los Angeles, Madison, Nashville, Newark, New Orleans, New York City, Philadelphia, San Francisco, Santa Fe, Seattle, St. Louis, Tampa, and Washington, DC. For details and local contact information, call the Boehringer Ingelheim study hotline at 800-632-2464; www.clinicaltrials.gov/ct/show/NCT00062660. (BI 1182.58)

TNX-355: New Entry Inhibitor

This double-blind Phase II study, sponsored by Tanox, will compare an investigational entry inhibitor, TNX-355, plus optimized background therapy (OBT) against OBT alone in treatment-experienced individuals with resistant HIV. OBT will be selected based on subjects' past medication history and resistance tests, and may not include another entry or fusion inhibitor. Subjects will be randomly assigned to receive TNX-355, placebo, or alternating TNX-355 and placebo administered by intravenous infusion every week for eight weeks, then every two weeks until week 48. Participants who experience virological failure after week 16 will have the option of trying a new optimized background regimen plus open-label TNX-355; those who experience a second failure will be taken off the study.

Eligible subjects must be at least 18 years old. They must have an HIV viral load of at least 10,000 copies/mL, have been on stable highly active antiretroviral therapy (HAART) for at least four weeks at study entry, have a cumulative history of HAART use of at least six months, have used all three established classes of antiretroviral drugs (nucleoside reverse transcriptase inhibitors [NRTIs], non-nucleoside reverse transcriptase inhibitors [NNRTIs], and PIs), and have experienced virological failure with their current or a previous regimen. However, their HIV must be susceptible to at least one drug in the OBT regimen. Subjects may not have previously used HIV entry or fusion inhibitors. Other exclusion criteria include various medical conditions or abnormal lab tests and use of certain medications or vaccines. Women may not be pregnant or breast-feeding and participants must agree to use effective contraception.

UK-427,857: Two Studies Starting

In December two trials began to study the safety and antiviral efficacy of UK-427,857, an investigational HIV entry inhibitor. Both are sponsored by the drug's manufacturer, Pfizer. In lab studies UK-427,857 -- a reversible CCR5 coreceptor antagonist -- was shown to be active against HIV, including virus resistant to existing classes of antiretroviral drugs. In early clinical trials UK-427,857 appeared safe in more than 400 subjects who took the drug for 28 days.

1) The first study will compare UK-427,857 vs. efavirenz (Sustiva) in individuals starting anti-HIV therapy for the first time. In this Phase I/II study subjects will be randomly assigned to receive 300 mg UK-427,857 once daily, 300 mg UK-427,857 twice daily, or efavirenz. Subjects in all three arms will also take AZT (zidovudine, Retrovir) and 3TC (lamivudine, Epivir). The treatment period will last 96 weeks, and may be extended depending on results at that point. Treatment involves regular clinic visits, some of which will include blood draws, electrocardiograms (heart rhythm monitoring), computerized tomography (CT, CAT) scans, and symptom questionnaires.

Eligible subjects must be at least 16 years old and have viral loads of at least 2,000 copies/mL. Exclusion criteria include various medical conditions or abnormal lab tests and current or prior use of certain medications (including efavirenz, AZT, or 3TC for more than 14 days). Women may not be pregnant or breast-feeding and participants must agree to use effective contraception.

2) The second study will compare UK-427,857 plus OBT vs. OBT alone in treatment-experienced individuals. In this Phase II/III study subjects will receive an optimized antiretroviral regimen as determined by treatment history and resistance testing. In addition, they will be randomly assigned to receive 150 mg UK-427,857 once daily, 150 mg UK-427,857 twice daily, or placebo. The treatment period will last 48 weeks and may be extended for an additional year. Treatment involves regular clinic visits, some of which will include blood draws and electrocardiograms.

Eligible subjects must be at least 16 years old and have viral loads of at least 5,000 copies/mL. They must have been on stable HAART, or else no antiretroviral therapy, for at least four weeks. Subjects must have six months' cumulative experience with or documented resistance to three of the four existing classes of anti-HIV medications. Exclusion criteria include various medical conditions or abnormal lab tests and current or prior use of certain medications (including other experimental entry inhibitors). Women may not be pregnant or breast-feeding and participants must agree to use effective contraception.

This study aims to enroll 500 participants at 100 U.S. and Canadian centers, including Dallas, Huntersville, NC, and New York City. For more information, call 734-622-7600; www.clinicaltrials.gov/ct/show/NCT00098306. (A4001027)

SMART: Drug Conservation vs. Viral Suppression

The SMART study, conducted by the CPCRA, is a large, simple trial comparing two HIV treatment strategies. The study will attempt to determine whether participants at low risk of HIV disease progression can safely reduce their use of antiretroviral therapy, thus minimizing side effects, slowing the development of drug resistance, and conserving future treatment options. Participants randomly assigned to the viral suppression arm (the "GO" group) will continue, or start, treatment in an attempt to keep viral load as low as possible, regardless of CD4 cell count. Those assigned to the drug conservation arm (the "WAIT" group) will stop, or not start, anti-HIV therapy until their CD4 cell counts fall below 250 cells/mm3, at which point they will begin therapy and continue until their CD4 cell counts rise above 350 cells/mm3. Some 6,000 participants will be followed for an estimated 6-9 years, until about 900 primary events (disease progression or death) occur.

Participants must be at least 13 years old and have CD4 cell counts above 350 cells/mm3 within 45 days of study entry. Subjects may be using any available antiretroviral or immune-modulating drugs at study entry. They must be in reasonably good health and available to continue the study for at least six months. Women may not be pregnant or breast-feeding and participants must be willing to use effective contraception.

When to Start HAART in People With OIs

This study will attempt to determine the best time to start antiretroviral therapy in individuals presenting with opportunistic illnesses (OIs). Immediately starting HAART may be disadvantageous since anti-HIV drugs can lead to immune reconstitution syndrome (IRIS) and can interact with drugs used to treat OIs. This trial will compare the benefits and drawbacks of starting antiretroviral therapy immediately vs. waiting until after OI treatment is underway or completed. Participants will be randomly assigned to either begin antiretroviral therapy within two months of starting OI treatment, or to defer anti-HIV treatment until at least four weeks -- but no more than 32 weeks -- after beginning OI therapy. All subjects will receive Kaletra (lopinavir/ritonavir) plus d4T (stavudine, Zerit), and may also receive a third and fourth anti-HIV drug at the discretion of study clinicians. The study will last 48 weeks and participants will have ten study visits, which will include blood tests, physical exams, and questionnaires.

Eligible participants must be at least 13 years old. They must have a confirmed or suspected acute OI, including Pneumocystis carinii pneumonia (PCP), bacterial pneumonia, cryptococcal meningitis, disseminated histoplasmosis, disseminated Mycobacterium avium complex (MAC), cytomegalovirus (CMV) retinitis or encephalitis, or toxoplasmic encephalitis. Participants may not have been on antiretroviral therapy within six months of study entry or for a total of six months at any time, and may not have been treated for their current OI for more than 14 days before study entry. Various medical conditions and recent use of certain medications are excluded. Women may not be pregnant or breast-feeding and subjects must be willing to use effective contraception.

Decreased Mental Function: Selegiline Patch

This double-blind Phase II study will examine whether the selegiline transdermal system (skin patch) is safe and effective in treating decreased mental function in people with HIV. Currently oral selegiline (Eldepryl) is approved for the treatment of Parkinson's disease. Prospective subjects will undergo blood draws, lumbar punctures (spinal taps), and neuropsychological screening tests to determine cognitive function. Participants will be randomly assigned to receive patches with one of two doses of selegiline or placebo (inactive) patches, to be applied daily. Study visits will take place at weeks 4, 8, 12, 16, and 24. Visits at weeks 12 and 24 will include mental function tests and surveys; the week 24 visit will include another lumbar puncture. Participants who complete the first 24-week stage of the trial will have the option to take part in an additional 24-week, open-label stage.

Eligible participants must be at least 18 years old and have impaired mental functioning as indicated by prestudy screening tests. There are no CD4 cell count or viral load restrictions. Participants must have been on stable antiretroviral therapy for eight weeks before study entry, or off treatment for those eight weeks due to drug resistance or intolerance. Exclusion criteria include various medical conditions (including AIDS-defining OIs and use of certain medications). Women may not be pregnant or breast-feeding.

A substudy of ACTG A5090, known as ACTG A5114s, will use magnetic resonance spectroscopy (MRS; a type of noninvasive brain imaging) to compare the extent of cerebral injury and functionality in people with memory impairment before and after using selegiline patches. MRS will be performed at study entry and at week 24. Participants enrolled in ACTG A5090 are eligible for the substudy, which aims to enroll 90 subjects at about half the sites conducting the parent study, including those in Baltimore, Los Angeles, New York City, Philadelphia, Rochester, San Diego, and Seattle; www.clinicaltrials.gov/ct/show/NCT00027040. (ACTG A5114s)

Acetyl-L-Carnitine for NRTI-Associated Neuropathy

This study will attempt to determine whether acetyl-L-carnitine reduces pain, numbness, and tingling in the lower extremities of individuals with peripheral neuropathy associated with the use of NRTI drugs. Subjects will start with one acetyl-L-carnitine tablet twice daily, increasing to three tablets daily for the duration of the 24-week trial; this is an open-label study with no placebo arm. Participants will undergo regular clinic visits, some of which require fasting blood draws; they will also have two small skin biopsies at enrollment and at the end of the study.

Eligible subjects must be at least 13 years old and have evidence of predominantly sensory neuropathy. Their HIV viral loads must be below 10,000 copies/mL within 60 days of study entry. For at least eight weeks they must have been on stable antiretroviral regimens that include at least one dideoxynucleoside analog (NRTI) drug, such as ddI (didanosine, Videx) or d4T. Exclusion criteria include various medical conditions and use of certain drugs (including recently started pain medications or other investigational agents). Women may not be pregnant or breast-feeding and participants must agree to use effective contraception.

This study aims to enroll 36 participants at about ten sites, including Baltimore (410-614-2766), Chicago (312-572-4545), Galveston (409-747-0241), New York City (212-746-4393), Sacramento (214-590-0414), Seattle (206-731-8877), and St. Louis (314-454-0058); www.clinicaltrials.gov/ct/show/NCT00050271. (ACTG A5157)

Capsaicin for Neuropathy Pain

This trial will study the safety and efficacy of capsaicin (chili pepper extract) in treating HIV-associated neuropathy. Previous research has shown that capsaicin can help relieve neuropathic pain. In this double-blind Phase III study, sponsored by NeurogesX, subjects will be randomly assigned to use NGX-4010, a high-concentration capsaicin patch, or placebo for 12 weeks.

Eligible subjects must be at least 18 years old and have had HIV-associated neuropathy with moderate-to-severe pain in both feet for at least two months. Exclusion criteria include various medical conditions, history of substance abuse, and use of other topical pain medications. Women may not be pregnant.

This study will be conducted at about 20 sites, including Annandale, VA (703-560-4821), New York City (212-241-0784), and Sarasota (941-366-0776). Contact NeurogesX at 605-508-2116 or visit the web site for more locations; www.clinicaltrials.gov/ct/show/NCT00085761. (C112)

Peripheral Neuropathy Pain: Medical Marijuana

This Phase II study will assess whether smoked marijuana helps relieve pain from peripheral neuropathy due to HIV itself or as a side effect of antiretroviral therapy. A recently completed pilot study showed that medical cannabis is effective for this indication; the current study will extend the research to a larger number of participants. Subjects will be housed at San Francisco General Hospital for seven days, where they will be randomly assigned to smoke either marijuana or placebo cigarettes three times daily. A heat/capsaicin pain test will be administered at the beginning of the study and at the end of the inpatient stay. Participants who complete the study will be compensated $650.

Prospective participants must be at least 18 years old and have painful HIV-related neuropathy. They must have been on a stable antiretroviral regimen, or else no anti-HIV treatment, for at least the previous eight weeks. They must have used marijuana on at least six occasions in the past, but not within 30 days of study entry. There are no CD4 cell count or viral load restrictions. Subjects may not have diabetes, uncontrolled high blood pressure, or heart or lung disease, and must not be using certain medications (including corticosteroids). Current tobacco users are not eligible. Women may not be pregnant or breast-feeding.

Alpha-Lipoic Acid for Painful Neuropathy

This Phase I/II study will look at alpha-lipoic acid, a naturally occurring antioxidant, for the treatment of painful HIV-related neuropathy. Previous research has shown that the agent significantly improves pain associated with diabetic neuropathy. Subjects will be randomized to receive daily oral doses of alpha-lipoic acid (600 mg three times daily) or placebo for 24 weeks.

Eligible subjects must be at least 18 years old and have diagnosed distal sensory peripheral neuropathy with pain or paresthesias (unusual sensations), with or without numbness or weakness. They must have been on a stable antiretroviral regimen, or else no anti-HIV treatment, for 12 weeks before study entry. Exclusion criteria include significant cognitive impairment, other potential causes of neuropathy besides HIV, and use of certain medications. Women may not be pregnant and must agree to use effective contraception.

Fish Oil Plus Fenofibrate for High Triglycerides

This study will examine whether fish oil plus fenofibrate (Tricor) can help reduce elevated triglyceride levels in people taking antiretroviral therapy. In particular, the trial will study the effect of the combination in individuals who have not responded to either fish oil or fibrate drugs alone. In this open-label Phase II trial, participants will first be randomly assigned to receive either fish oil supplements containing omega-3 fatty acids or fenofibrate. Those who show a response at week 8 will stay on the single therapy through week 18; those who do not respond by week 10 will add the agent they did not initially receive, and will take both through week 18. Participants will be assigned to a lipid-lowering diet and exercise program that begins a month before study entry and continues for the duration of the trial. Subjects will have regular clinic visits that include fasting blood draws. There will also be a follow-up visit at week 22. Subjects will continue their existing HAART regimens throughout the study.

Eligible participants must be at least 18 years old and have been on HAART for at least three months before study entry, and on an unchanged regimen for at least four weeks. They must have fasting LDL "bad" cholesterol levels of 160 mg/dL or less and fasting serum triglyceride levels of 400 mg/dL or greater within 28 days of study entry. Exclusion criteria include various medical conditions (including coronary heart disease, atherosclerosis, uncontrolled high blood pressure, and diabetes) and use of certain medications (including recent use of other lipid-lowering agents). Women may not be pregnant or breast-feeding and must agree to use effective contraception.

Bone Mineral Density: Alendronate, Calcium, and Vitamin D

This study will examine the effects of alendronate (Fosamax), calcium, and vitamin D on bone mineral density in people with HIV. Research has shown that HIV positive individuals appear to be at greater risk for bone loss (osteopenia and osteoporosis) due to antiretroviral therapy or HIV itself. In this Phase II safety and efficacy study, participants will be randomly assigned to receive either alendronate or placebo for 48 weeks; all subjects will receive calcium and vitamin D supplements. Participants will have regular clinic visits, which will include fasting blood draws and dual energy x-ray absorptiometry (DEXA) scans to evaluate bone density.

Eligible subjects must be at least 25 years old and have decreased bone mineral density as shown by a lumbar spine DEXA scan within 90 days of study entry. Subjects must have been on stable antiretroviral therapy for at least 12 weeks before enrollment, and must have CD4 cell counts of at least 100 cells/mm3 and HIV viral loads of 5,000 copies/mL or less. They must also have a serum calcium level between 8 and 11 mg/dL. Men may not have untreated hypogonadism (low testosterone), and women on estrogen replacement therapy and individuals on steroids must have been on stable regimens for at least 24 weeks. Exclusion criteria include various medical conditions (including esophagitis and recent spinal fractures) and use of certain medications and supplements (including glucocorticoids, calcium, vitamin D, or high doses of vitamin A). Women may not be pregnant or breast-feeding and must agree to use effective contraception.

Therapeutic Vaccine Plus Treatment Interruption

This study will examine the effectiveness of an HIV therapeutic vaccine followed by treatment interruption. It is intended to test the theory that vaccination may generate a long-term immune response against HIV if given while viral replication is controlled by antiretroviral therapy. While still taking their antiretroviral medications, participants will be randomly assigned to receive either the MRK Ad5 HIV-1 Gag vaccine (which uses a replication-defective adenovirus vector) or placebo injections on day 1 of the study and at weeks 4 and 26. Three months after the final injection, they will stop taking their anti-HIV drugs, and changes in viral load and CD4 cell count will be observed for four months. After this period participants will have the option of restarting anti-HIV therapy or continuing without medication; they will be followed every two months for eight more months. Further follow-up by phone will continue biannually for an additional 3.5 years.

Eligible participants must be at least 18 years old, HIV positive, and have been on stable antiretroviral therapy for at least four weeks. They must have viral loads below 50 copies/mL at study entry and documented viral suppression (below 500 copies/mL) for the two preceding years, but must have had at least one documented viral load measurement of 1,000 copies/mL or more within the two years before starting antiretroviral treatment. CD4 cell counts must be at least 500 cells/mm3. Participants may not be coinfected with hepatitis B or C and may not have a history of OIs or various conditions (including heart, liver, or kidney disease). They may not be taking certain drugs and may not have received certain other vaccines. Women may not be pregnant or breast-feeding and participants must agree to use effective contraception.

Other Therapeutic Vaccine Strategies

Other smaller therapeutic vaccine trials are recruiting participants at single sites.

1) In one nonrandomized, open-label study, ten subjects will receive injections of an HIV-antigen-bearing dendritic cell vaccine. They will then stop their antiretroviral medications, and CD4 cell count and viral load will be monitored for 12 weeks. Eligible participants must be 18-60 years old and may be either HIV positive or negative. They must have baseline CD4 cell counts of at least 400 cells/mm3 and, if HIV positive, viral loads below 50 copies/mL; positive subjects also must have started antiretroviral therapy within 120 days of infection. Participants must also have the HLA-A*0201 (HLA A2.1) blood type. There are various exclusion criteria related to medical conditions and use of other medications. Women may not be pregnant or breast-feeding.

2) Another study is looking at the immune-enhancing properties of a vaccine made from participants' own (autologous) dendritic cells in subjects who remain on HAART throughout the trial. Two doses of dendritic cells will be tested, and subjects will be followed for 48 weeks. Participants must have at least 400 CD4 cells/mm3, viral loads below 400 copies/mL, and the HLA-A*0201 blood type. There are various exclusion criteria related to medical conditions, use of other medications and vaccines, and pregnancy.

3) A third study is looking at whether a recombinant HIV-specific canarypox vaccine known as ALVAC vCP1452, with or without low-dose interleukin 2 (IL-2, Aldesleukin), can control HIV viral load after antiretroviral therapy is stopped. Participants will be randomly assigned to receive either the active vaccine alone, placebo alone, IL-2 plus active vaccine, or IL-2 plus placebo. The vaccine, placebo, and IL-2 all require multiple injections. In step 2 of the study subjects in all arms will stop HAART for at least 12 weeks, and viral load will be monitored. Participants whose viral loads stay below 30,000 copies/mL will remain off HAART and continue weekly viral load monitoring. Those whose viral loads increase to more than 30,000 copies/mL or whose CD4 cell counts fall below 200 cells/mm3 will restart antiretroviral therapy. Eligible participants must be at least 19 years old and have been on their current HAART regimen for more than six consecutive months. They must have CD4 cell counts of at least 400 cells/mm3 within 30 days of study entry and at least 200 cells/mm3 during the past year. Viral load must be below 50 copies/mL within 30 days of study entry. There are various exclusion criteria related to medical conditions and use of other medications. Women may not be pregnant or breast-feeding.

Project T: Tenofovir to Prevent HIV Infection

This study, coordinated by the Centers for Disease Control and Prevention (CDC), is part of a larger international research program to determine whether the nucleotide reverse transcriptase inhibitor tenofovir DF (Viread) can help prevent HIV infection. The drug has performed well in animal prophylaxis studies and appears to have fewer side effects than other antiretroviral medications. The U.S. phase of the study will focus on the clinical and behavioral safety of the drug, not its effectiveness. In particular, researchers will attempt to determine whether using a potentially preventive drug will lead to an increase in risky sexual behavior. Participants in arm A will receive either 300 mg daily oral tenofovir or placebo; those in arm B will wait nine months before starting therapy. Because it is not yet known whether tenofovir can help prevent HIV infection -- and because some subjects will be taking placebo -- participants should continue to practice safer sex, and will receive risk-reduction counseling and free condoms during the study. Should any participants become infected, the local research group will facilitate referrals for HIV care and treatment.

Eligible participants must be sexually active, HIV negative men who have sex with men between the ages of 18 and 60. The study is expected to last two years.

The U.S. arm of the study will enroll 200 gay and bisexual men at each of two sites, Atlanta (404-876-2317) and San Francisco (415-554-8888; www.sfaidsresearch.org).

ACE: Herpes Suppression to Prevent HIV Infection

The ACE study will examine whether suppression of genital herpes (herpes simplex virus type 2, or HSV-2) with acyclovir (Zovirax) can help reduce the risk of contracting HIV. Research to date indicates that having even subclinical (asymptomatic) HSV-2 infection without obvious lesions can increase the likelihood that an individual will contract or transmit HIV. Participants will be randomly assigned to receive either 400 mg acyclovir or placebo twice daily for 12 months. Those who develop genital herpes outbreaks will be treated with open-label acyclovir. Subjects will also receive risk-reduction counseling and free condoms. Study visits will take place every month and participants will be compensated for their time.

Eligible participants must be sexually active, HIV negative gay or bisexual men at least 18 years old with confirmed HSV-2 infection.

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